Apparatus for treating obesity

ABSTRACT

An apparatus for treating obesity in a human or animal mammal patient. The apparatus comprising a first volume filling device segment and a second volume filling device segment. The first and second volume filling device segments are adapted to be assembled into an implantable volume filling device of a controlled size. Each one of the first and second volume filling device segment comprises at least one interconnecting structure. The interconnecting structure of the second volume filling device segment is adapted to be formed fitted, such that the first and second volume filling device segment can be assembled into the volume filling device. The assembled volume filling device is adapted to be at least substantially invaginated by a stomach wall portion of a patient, with the outer surface of the device resting against the stomach wall, such that the volume of the food cavity is reduced in size.

This application is a continuation of U.S. patent application Ser. No.15/425,568, filed Feb. 6, 2017, and issued as U.S. patent Ser. No.10,660,777, which is a continuation of U.S. patent application Ser. No.13/123,014, filed Apr. 7, 2011, and issued as U.S. Pat. No. 9,561,033,which is the U.S. National Phase of International Application No.PCT/SE2009/051156, filed Oct. 12, 2009, which designated the U.S. andclaims priority to SE 0802138-8 filed Oct. 10, 2008, PCT/SE/2009/000047filed Jan. 29, 2009, PCT/SE/2009/000048 filed Jan. 29, 2009, SE0901007-5 filed Jul. 17, 2009, and the benefit of U.S. 61/213,813 filedJul. 17, 2009, the entire contents of each of which are herebyincorporated by reference.

TECHNICAL FIELD

The present invention relates to an apparatus, a system, and a methodfor treating obesity.

BACKGROUND

Obesity has been treated by gastric banding a band placed around thestomach to create a stoma, a restricted opening, to restrict the flow offood down to below the band. There has also been tried to use electricalstimulation of the stomach wall to cause the patient to feel satiety.

When the stomach gets distended the patient gets a feeling that thestomach is full.

Another prior art way of treating obesity is to insert a balloon-likeobject into the stomach of the patient. In this way, the patient isgiven the feeling of satiety much more quickly when eating, preventingexcessive intake of food. However, these prior art balloon-like objectsare subject to stomach acids, leading to their destruction within acouple of months of use.

An example of a prior art inflatable gastric device for treating obesityis disclosed in U.S. Pat. No. 4,246,893 to Berson. In this document, itis disclosed an abdominal method wherein an inflatable balloon issurgically implanted in the abdominal cavity of the patient adjacent tothe stomach. An adjusting port is provided subcutaneously and theballoon is subsequently inflated by means of inserting a hypodermicneedle through the skin of the patient into the adjusting port andintroducing a fluid under pressure into the port for passage into theballoon to distend the upper abdomen, compressing the stomach andthereby producing a sense of satiety.

SUMMARY

The object of the present invention to provide obesity treatmentapparatus, system and methods with improved long term properties.

This object and others are obtained by an apparatus described in theappended claims. In general terms, the present invention relates to anapparatus for treating obesity in a human or animal mammal patientcomprising two or more volume filling device segments adapted to beassembled to an implantable volume filling device of a controlled size.The assembled volume filling combination device is adapted to be atleast substantially be invaginated by a stomach wall portion of apatient, wherein said assembled volume filling device is adapted to beplaced with the outer surface of the device resting against the stomachwall, such that the volume of the food cavity is reduced in size by avolume substantially exceeding the volume of the assembled volumefilling device, when the assembled volume filling device is invaginatedin the stomach wall. The assembled volume filling device is adapted todisassemble into its volume filling device segments if the assembleddevice leaves its implanted invaginated stomach position andinadvertently penetrates the stomach wall to become located inside thestomach including penetrating the stomach wall to retain a positioninside the stomach, wherein said segments are adapted to separately passthrough the food, thereby reducing risk for causing obstruction/ileus inthe patients intestine. Preferably, the assembled volume filling devicehas a maximum circumference of at least 15 millimeters, and morepreferably of at least 30 millimeters. Preferably, the volume fillingdevice segments has at least part of an outer surface including abiocompatible material. By invaginating an assembled volume fillingdevice by the stomach wall on the outside thereof this device isprotected from the stomach acids and will thus remain functioning for avery long time.

According to one alternative, assembled the volume filling device isadapted to be placed inside the stomach with the outer surface of thevolume filling device resting against the inside of the stomach wall,such that the volume of the food cavity is reduced in size by a volumeexceeding the volume of the volume filling device. The volume fillingdevice is preferably adapted to be placed inside the stomach with agastroscope.

According to another alternative, assembled the volume filling device isadapted to be placed on the outside of the stomach wall with the outersurface of the volume filling device resting against the outside of thestomach wall, such that the volume of the food cavity is reduced in sizeby a volume substantially exceeding the volume of the volume fillingdevice. Preferably, the assembled volume filling device is adapted to becompletely invaginated by the stomach wall of the patient and to beplaced outside the stomach wall via a gastroscopic instrument.

To this end the volume filling device segments may comprise anattachment device adapted to co-operate with a gripping instrument.Suitably, the assembled volume filling device is adapted to benon-invasively adjustable postoperatively.

The assembled volume filling device preferably is adapted to disassembleinto its segments if it leaves its placed with the outer surface of thedevice resting against the stomach wall, i.e. its implanted at lastpartially invaginated position. The segments are preferably adapted toseparately pass through the food passage way, thereby reducing risk ofcausing obstruction/ileus in the patient's intestine. The volume fillingdevice segments can be adapted to pass through a trocar, for assemblyand implantation of said volume filling device into the abdominalcavity. The volume filling device segments can have a flexible outershape adapted to pass through a trocar. The volume filling devicesegments can be adapted to have a shape allowing them to be assembledinto the device when implanted. In embodiment, at least one of thevolume filling device segments have flexible outer surface. In oneembodiment, at least one of the volume filling device segments comprisesa rigid outer surface. In one embodiment, at least one of the volumefilling device segments is hollow with a flexible outer surface. In oneembodiment at least one of the volume filling device segments comprisesan enclosure wall defining a chamber. At least one of the volume fillingdevice segments can be adapted to be filled with at least one of a fluida foam, a gel or a fluid that hardens to a solid material. In oneembodiment the volume filling device segments comprises a homogenousand/or solid material, for example a solid body. In one embodiment atleast of said segments comprises a flexible, non-elastic material. Inone embodiment at least of said segments comprises a inflatable chamberand at least one tube connected thereto for supplementation of fluid tothe chamber. It is preferred that the volume filling device segments areadapted to temporary be holding their assembled position, preferably bythe invaginated stomach wall, or alternatively by an adhesive.

For its assembly, the volume filling device is provided with at leastone assembly element that sufficiently fits with at least one assemblyelement of another segment, so the segments by fitting assembly elementscan be assembled into the implantable volume filling device. Preferably,the segments for this purpose comprise a core part and a plurality ofouter parts, and preferably, the at least one assembly element isselected among sufficiently fitting flanges and slits. The core part isadapted to receive and assemble the outer elements into an implantablevolume filling device, and preferably the core part has assembly slitsadapted to receive corresponding assembly flanges of the outer partswhen assembling the volume filling device. In one embodiment the slitsare distributed around the outer peripheral area of the core part. Theouter parts are then provided with flanges sufficiently matching theslits to assemble the device. In another embodiment, the at least oneassembly element immobilizes each of the volume filling device segmentsto a core part along a first plane, and wherein movement, and whereinthe volume filling device segments and the core part further comprises asecond assembly element, which following the assembly of said segmentsand core part, immobilize each segment and core part along a secondplane in an angle to said first plane. For example, the first plane andthe second plane can be substantially perpendicular. The second assemblyelement comprises mating elements, preferably with matching protrusionsand recesses provided on the volume filling device segments and the corepart, while the at least one assembly element further comprisesprotrusions and recesses. Preferably, the at least one assembly elementcomprises an assembly slit in the core part and an assembly flange in asegment, and wherein a mating element comprises a protrusion in saidslit and a recess in said flange; or alternatively, the at least oneassembly element comprises an assembly flange in the core part and anassembly slit in a segment, and wherein the a mating element comprises aprotrusion in said slit and a recess in said flange.

In one particular embodiment, the apparatus preferably further comprisesa guiding device, operable for assembling the volume filling devicesegments to an implantable volume filling device. Preferably, theguiding device is an operation wire operably connected to the segments.

The operation wire can be made of a material that is biodegradable incontact with the body fluid in the abdominal cavity so as to facilitatedisassembly of the volume filling device into its segments. In order toassist with assembly procedure, each segment can be provided with atleast one assembly element that sufficiently fits with at least oneassembly element of another segment, so the segments by fitting assemblyelements can be assembled into the implantable volume filling device. Inone embodiment the segments comprise a core part and a plurality ofouter parts and in one embodiment wherein the assembly elements areselected among sufficiently fitting flanges and slits. The core partpreferably is adapted to receive and assemble the outer elements into animplantable volume filling device. In one embodiment the core part hasassembly slits adapted to receive corresponding assembly flanges of theouter parts when assembling the volume filling device. Preferably theslits are distributed around the outer peripheral area of the core part.The slits and flanges may be designed to have loose fit adapted keep thesegments together as a volume filling device at its implanted located,but assist with disassemble the device if it inadvertently leaves such aposition, for example to the stomach cavity. In such event thedegradation of the guiding device will also assist with disassemblingthe volume filling device into segments which are designed not cause anyobstructions or in any other form damage the patient.

In order to assemble the segments, the operation wire is connected tothe core part and to the outer parts so the outer parts can besequentially assembled to the core part so as to assemble the volumefilling device. For this purpose, the operation wire preferably isconnected to the assembly flanges of the outer part and preferably, thecore part is provided with at least one operation channel for receivingthe operation wire. Preferably, each outer part is connected to twooperation channels by the operation wire. In one embodiment, a firstoperation channel has a first orifice in an end surface of the core partand second orifice in a first slit of the core part, so when displacingthe operation wire received in said first operation channel in adirection from said end surface, a first outer part is assembled to saidcore part. A second operation channel has two orifices in a second slitof the core part, so when displacing the operation wire connected to thefirst operation cannel in a directed from the end surface, a secondouter part is assembled to said core part. Preferably, the guiding wireprotrudes from the first channel orifice so it can be operated on withan instrument to displace the guiding wire and a first outer element soits assembly flange fits with its designated first assembly slit on thecore element, and in a predetermined sequence in the same mannerdisplacing the remaining outer elements so as to assemble theimplantable volume filling device. The segments can comprise three ormore outer parts assembled to designated slits of the core part with theguiding wire through operation channels having orifices in eachdesignated slit of said core part. In one embodiment the volume fillingdevice comprises one core part and four outer parts. However other waysof designing the segments within the present concept is feasibleaccording to the skilled person. The so assembled volume filling devicecan retain a generally spherical form, but as will be described laterother shapes and additional function elements are made part of thepresent invention.

The apparatus may comprise a fixation device, suitably two or morefixation devices, adapted to be involved in the fixation of the volumefilling device to the stomach wall. The volume filling device includingat least one of its segments may comprise a holding device adapted to beheld by an instrument, suitably two or more holding devices, to simplifythe implantation of the device.

At least a part of the assembled volume filling device may be made of amaterial which is not destructible by stomach acid. The volume fillingdevice may be destructible by acids, for example hydrochloric acid.

In an embodiment, the volume filling device including at least one ofits segments is inflatable to an expanded state and comprises anenclosure wall defining a chamber, wherein the volume filling device isinflated with a gel or fluid supplied into the chamber. At least onetube may be connected to the volume filling device for supplying gel orfluid to the chamber. An injection port connectible with the tube may beprovided. Alternatively, the volume filling member may be provided withan inlet port for a fluid or a gel connectible to a gastroscopicinstrument, wherein the inlet port comprises a fluid connection adaptedto interconnect the inflatable device and the gastroscopic instrument.

The volume filling device may include a homogenous material, such as gelhaving a shore value of less than 15. The device may also be a solidbody.

The volume filling device including at least one of its segments maycomprise a rigid, elastic or flexible outer surface. Where the outersurface is rigid, it is rigid enough to maintain non-deformed whensubject to forces created by stomach movements. The volume fillingdevice may comprise a flexible non-elastic material.

In accordance with a first general design of the volume filling device,the device has a maximum circumference as seen in a plane perpendicularto an axis through the device. The circumferences of the device as seenin other planes perpendicular to said axis are equal to the maximumcircumference or decrease as seen along said axis in the direction fromthe maximum circumference. For example, the device may be substantiallyegg shaped, spherically shaped, or substantially shaped like an egg withan indented middle section or like a bent egg.

In accordance with a second general design of the device, thecircumference of the device as seen in a plane perpendicular to an axisthrough the device increases and decreases at least two times as theplane is displaced along said axis, or decreases and increases at leastone time as the plane is displaced along said axis. For example, thedevice may be substantially shaped like a kidney.

The assembled volume filling device in yet another embodiment has acircumference as seen in a plane perpendicular to an axis through thebody, and wherein the circumference constantly increases or remainsconstant when moving along said axis from a first end point of said axisto a intermediate point with a maximum, and the circumference constantlydecreases or remains constant when moving from said intermediate pointto a second end point of said axis.

The assembled volume filling device in yet another embodiment has acircumference as seen in a plane perpendicular to an axis through thebody, and wherein the circumference constantly increases or remainsconstant when moving along said axis from a first end point of said axisto a first intermediate point with a first maximum, the circumferenceconstantly decreases or remains constant when moving from said firstintermediate point to a second intermediate point with a first minimum,the circumference constantly increases or remains constant when movingalong said axis from said second intermediate point of said axis to athird intermediate point with a second maximum, and the circumferenceconstantly decreases or remains constant when moving from said thirdintermediate point to a second end point of said axis.

More embodiments are described below:

The assembled volume filling device and/or one or more of the volumefilling device segments may have an elongated, rounded, bent and/orcurved shape.

The assembled volume filling device has a circumference of at least 30,50, 80 120, 150, 180 or 220 mm.

The assembled volume filling device has a volume in the range of 0.0001to 0.001 m³, or 0.00001 to 0.001 m³, or 0.00001 to 0.0002 m³. The volumeof the volume filling device has in yet another embodiment a volume ofless than 0.0002 m³.

The volume filling device may comprise at least two interconnectableportions adapted to be placed inside the stomach as separate portions.

The volume filling device including at least one of its segments maycomprise an elastic material, a bio-compatible material and/or silicone.

Suitably, the volume filling device is provided with at least one layer.For example, a metal layer, a Parylene layer, a polytetrafluoroethylenelayer or a polyurethane layer. The layers may comprise multiple layersin any order. Suitably, one of the layers may be made of made of metal,silicon or PTFE. The volume filling device may comprise an outer surfacelayer of silicone, polyurethane, Teflon®, or polytetrafluoroethylene,metal, parylene, PTFE or a combination thereof. The volume fillingdevice may comprise an inner surface layer of silicone, polyurethane,Teflon®, or polytetrafluoroethylene, metal, parylene, PTFE or acombination thereof. Other combinations include an inner surface layerof polytetrafluoro-ethylene and an outer layer of silicone, an innersurface layer of polytetrafluoroethylene, an intermediate layer ofsilicone, and an outer layer of Parylene, an inner surface layer ofpolyurethane and an outer layer of silicone, and an inner surface layerof polyurethane, an intermediate layer of silicone, and an outer layerof Parylene.

The volume filling device including at least one of its segments maycomprise a fluid adapted to be transformed into solid state or fixedform. Such a fluid may be liquid polyurethane or isotonic. The fluid maycomprises large molecules, such as iodine molecules, to preventdiffusion.

The volume filling device may have a maximum circumference of at least50 millimeters, preferably at least 80 millimeters. Suitably, the volumefilling device is deformable to a maximum diameter, so as to beinsertable into a laparoscopic trocar.

Preferably, the assembled volume filling device is adapted to be kept inplace by stomach-to-stomach sutures or staples to invaginate the devicein the stomach wall. Advantageously, the volume filling device hasvarying circumference to better be kept in place invaginated in thestomach wall of the patient. The stomach-to-stomach sutures or staplesmay be provided with fixation portions exhibiting a structure adapted tobe in contact with the stomach wall to promote growth in of human tissueto secure long term placement of the volume filling device attached tothe stomach wall. The structure may comprise a net like structure.

In embodiment of the invention, the apparatus comprises a stretchingdevice placed outside the stomach wall and adapted to stretch a portionof the stomach wall, thereby affecting the patient's appetite. Where thevolume filling device including at least one of its segments isinflatable, the apparatus may comprise a fluid connectioninterconnecting the stretching device and the volume filling device.

In an embodiment, the apparatus comprises at least one operablestretching device implantable in an obese patient and adapted to stretcha portion of the patient's stomach wall and an operation device foroperating the stretching device when implanted to stretch the stomachwall portion such that satiety is created.

In an embodiment, the apparatus comprises at least one operablestretching device implantable in the patient and adapted to stretch aportion of the patient's stomach wall, and an implantable control unitfor automatically controlling the operable stretching device, when thecontrol unit and stretching device are implanted, to stretch the stomachwall portion in connection with the patient eating such that satiety iscreated.

In an embodiment, the apparatus comprises at least one operablestretching device implantable in an obese patient and adapted to stretcha portion of the patient's stomach wall, wherein said stretching devicecomprising an expandable stretching reservoir and an operation devicefor operating the stretching device when implanted to stretch thestomach wall portion, wherein the volume filling device is inflatableand in fluid connection with said stretching reservoir, wherein saidoperation device comprises a pump for pumping fluid between said mainreservoir and said stretching reservoir to stretch said stomach wallportion such that satiety is created. A control device may be providedfor controlling said stretching device including said pump. The controldevice may comprise a wireless remote control adapted to control thestretching device from the outside of the patient's body, or animplantable control unit for controlling said stretching device.Alternatively, the control device may comprise a subcutaneously placedswitch or reservoir adapted to control the stretching device from theoutside of the patient's body. A sensor or sensing device to beimplanted in the patient body may be provided, wherein the implantablecontrol unit is adapted to control the stretching device from the insideof the patient's body using information from said a sensor or sensingdevice, adapted to sense, direct or indirect, the food intake of thepatient.

In an embodiment, the assembled volume filling device comprises a mainvolume filling reservoir, a stretching device comprising at least oneoperable stretching device implantable in an obese patient and adaptedto stretch a portion of the patient's stomach wall, wherein saidstretching device comprising an expandable reservoir, adapted to beinvaginated in the stomach wall at the upper part of the stomach, higherup than the inflatable main volume filling device when the patient isstanding, wherein the volume filling device is inflatable and in fluidconnection with said stretching reservoir, wherein normal contractionsof the stomach wall, related to food intake, cause fluid to flow fromsaid invaginated main volume filling reservoir lower placed onto thestomach wall adapted to cause said stretching reservoir to stretch saidstomach wall portion such that satiety is created. The fluid connectionbetween the main volume filling device reservoir and the stretchingreservoir comprises a non-return valve. The fluid connection between themain volume filling device reservoir and the stretching reservoircomprises a release function adapted to release the volume in thestretching reservoir back to the main volume filling device reservoir.Said release function may comprise a fluid return connection of asubstantially smaller area than said fluid connection, to slowly releaseback fluid to said main volume filling device reservoir from thestretching reservoir to release said stretching of the stomach wallportion. A further manual control device comprising a subcutaneouslyplaced reservoir adapted to control the stretching device from theoutside of the patient's body may be provided to further affect thestretching device to stretch the stomach wall portion.

In an embodiment, the a main volume filling device reservoir adapted tobe inflatable may be provided, wherein the volume filling device furthercomprises an expandable structure, adapted to expand, when the device isinvaginated in the stomach wall, wherein said structure comprising abellow adapted to take into account the fibrosis surrounding the devicewhen implanted, such that the movement of the bellow is substantiallyun-affected of said fibrosis.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall andwherein the stretching device comprising a expandable structure, adaptedto expand and stretch the stomach wall portion, when the device isinvaginated in the stomach wall, wherein said structure comprising aspecial bellow adapted to take into account the fibrosis surrounding thedevice when implanted, such that the movement of the bellow issubstantially un-affected of said fibrosis. An operation device foroperating the stretching device may be provided to stretch the stomachwall portion such that satiety is created. The apparatus may comprise animplantable control unit for automatically controlling the operablestretching device, when the control unit and stretching device areimplanted, to stretch the stomach wall portion in connection with thepatient eating such that satiety is created.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall such thatsatiety is created. The control device may comprise a wireless remotecontrol adapted to control the stretching device from the outside of thepatient's body or an implantable control unit for controlling saidstretching device. Alternatively, said control device may comprise asubcutaneously placed switch or reservoir adapted to control thestretching device from the outside of the patient's body. A sensor orsensing device adapted to be implanted in the patient body may beprovided, wherein the implantable control unit is adapted to control thestretching device from the inside of the patient's body usinginformation from said sensor or sensing device, adapted to sense, director indirect, the food intake of the patient.

In an embodiment, the apparatus further comprises a stretching devicecomprising three or more mechanical parts engaged with different partsof the stomach wall, one part each, wherein said engagement includessuturing or stapling to the stomach wall or invaginating the mechanicalparts in the stomach wall part with stomach to stomach sutures, whereinthe three or more mechanical parts are adapted to move in relation toeach other adapted to stretch three different wall portions, thestretching device further adapted to having said wall portions stretchedindependently from each other both regarding force used for stretchingthe stomach wall portion as well as, time periods the stretching isapplied, and when the stretching is applied.

In an embodiment, the apparatus further comprises a stretching devicecomprising two or more hydraulic parts engaged with different parts ofthe stomach wall, one part each, wherein said engagement includessuturing or stapling to hydraulic part to the stomach wall orinvaginating the hydraulic parts in the stomach wall part, with stomachto stomach sutures, wherein the two or more hydraulic parts are adaptedto move in relation to each other adapted to stretch three differentwall portions, the stretching device further adapted to having said wallportions stretched independently from each other both regarding forceused for stretching the stomach wall portion as well as, time periodsthe stretching is applied, and when the stretching is applied.

In an embodiment, the apparatus further comprises a stretching device isengaged with a part of the stomach wall, including suturing or staplingthe stretching device to the stomach wall or invaginating the stretchingdevice in the stomach wall part, with stomach to stomach sutures,wherein the stretching device is further adapted to stretch a stomachwall portion controlling force used for stretching the stomach wallportion as well as, time periods the stretching is applied, and when thestretching is applied.

In an embodiment, the apparatus further comprises a stretching devicecomprising two parts engaged with different parts of the stomach wall,one part each, wherein said engagement includes suturing or stapling theparts to the stomach wall or invaginating the parts in the stomach wallpart, with stomach to stomach sutures, wherein the stretching devicefurther adapted to have different wall portions stretched independentlyfrom each other controlling force used for stretching the stomach wallportion as well as, time periods the stretching is applied, and when thestretching is applied.

In an embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable volume fillingdevice adapted to be at least partly invaginated by the patient'sstomach fundus wall and having an outer surface that includes abiocompatible material, wherein a substantial part of the outer surfaceof the volume filling device is adapted to rest against the stomach wallwithout injuring the latter in a position between the patient'sdiaphragm and at least a portion of the lower part of the invaginatedstomach fundus wall, such that movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, whenthe volume filling device is invaginated, to thereby prevent the cardiafrom sliding through the patient's diaphragm opening into the patient'sthorax, so as to maintain the supporting pressure against the patient'scardia sphincter muscle exerted from the patient's abdomen, the volumefilling device having a size of at least 125 mm³ and a circumference ofat least 15 mm.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable volume fillingdevice having an outer surface including a biocompatible material,wherein the movement restriction device is adapted to rest with at leasta part of its outer surface against the patient's stomach fundus wall,in a position between the patient's diaphragm and the fundus wall, suchthat movement of the cardiac notch of the patient's stomach towards thepatient's diaphragm is restricted, when the movement restriction deviceis implanted in the patient, to thereby prevent the cardia from slidingthrough the patient's diaphragm opening into the patient's thorax, so asto maintain the supporting pressure against the patient's cardiasphincter muscle exerted from the patient's abdomen, wherein the volumefilling device having a size of at least 125 mm3 and a circumference ofat least 15 mm, and an a fixation device adapted to secure the volumefilling device in said position, when the volume filling device isimplanted.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device adapted to be at least partly invaginated by thepatient's stomach fundus wall and having an outer surface that includesa biocompatible material, wherein a substantial part of the outersurface of the movement restriction device is adapted to rest againstthe stomach wall without injuring the latter in a position between thepatient's diaphragm and at least a portion of the lower part of theinvaginated stomach fundus wall, such that movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restricted,when the movement restriction device is invaginated, to thereby preventthe cardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,the movement restriction device having a size of at least 125 mm³ and acircumference of at least 15 mm, further comprising a stretching devicecomprising at least one operable stretching device implantable in theobese patient and adapted to stretch a portion of the patient's stomachwall such that satiety is created.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device having an outer surface including a biocompatiblematerial, wherein the movement restriction device is adapted to restwith at least a part of its outer surface against the patient's stomachfundus wall, in a position between the patient's diaphragm and thefundus wall, such that movement of the cardiac notch of the patient'sstomach towards the patient's diaphragm is restricted, when the movementrestriction device is implanted in the patient, to thereby prevent thecardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,wherein the movement restriction device having a size of at least 125mm3 and a circumference of at least 15 mm, and a fixation device adaptedto secure the movement restriction device in said position, when themovement restriction device is implanted, further comprising astretching device comprising at least one operable stretching deviceimplantable in the obese patient and adapted to stretch a portion of thepatient's stomach wall such that satiety is created.

In an embodiment, the apparatus further comprises an external controlunit for controlling the volume filling device from the outside of thepatient's body. The external control unit may comprise a wireless remotecontrol adapted to control the device from the outside of the patient'sbody. Alternatively, the external control unit may comprise asubcutaneously placed switch or reservoir adapted to control the devicefrom the outside of the patient's body.

In an embodiment, the apparatus further comprises a sensor or sensingdevice adapted to be implanted in the patient body, wherein theimplantable control unit is adapted to control the device from theinside of the patient's body using information from said a sensor orsensing device, adapted to sense, direct or indirect, the food intake ofthe patient.

In accordance with another aspect of the present invention, there isprovided an apparatus for treating obesity of an obese patient having astomach with a food cavity, the apparatus comprising at least one volumefilling device adapted to be at least substantially invaginated by astomach wall portion of the patient and having an outer surface thatincludes a biocompatible material, wherein the volume filling device isadapted to be placed inside the stomach with the outer surface of thevolume filling device resting against the inside of the stomach wall,such that the volume of the food cavity is reduced in size by a volumesubstantially exceeding the volume of the volume filling device, thevolume filling device having a maximum circumference of at least 30millimeters.

In a preferred embodiment, the apparatus comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe volume filling device.

In another preferred embodiment, the apparatus comprises a wirelessremote control for non-invasively controlling the volume filling device.

In a preferred embodiment, the apparatus comprises a hydraulic operationdevice for operating volume filling device.

In one embodiment, the apparatus comprises comprising a motor or a pumpfor operating the volume filling device.

In one embodiment the apparatus comprises an adjustment device foradjusting the size and/or shape of the volume filling device includingat least one of its segments. The size of the volume filling device canbe hydraulically adjustable and the adjustment device comprises ahydraulic fluid reservoir that, when implanted in the patient, isconnected to at least one of the volume filling device segments, andwherein the size of the volume filling device is non-invasivelyregulated by moving hydraulic fluid from the reservoir to at least onevolume filling device segment, thereby adjusting the size of at leastone segment of the volume filling device. The apparatus can furthercomprise hydraulic regulation device comprising at least one chamberthat, when implanted in the patient, is invaginated in the patient'sstomach wall with the volume filling devices and in being connectiontherewith, and wherein the amount of hydraulic fluid contained in atleast one of the volume filling device segments is non-invasivelyregulated by distributing fluid between the hydraulic reservoir and theat least one chamber. Preferably, the at least one chamber, whenimplanted in the patient, is filled with the hydraulic fluid using apump in the reservoir so as to stretch the fundus wall to create satietyin the patient. The adjustment device can further comprise a reverseservo comprising three adjustable reservoirs with hydraulic fluid,wherein a small volume of fluid in a first reservoir placedsubcutaneously, being part of a first closed system including a secondreservoir, is compressed with a high force per area unit for moving asmall volume of hydraulic fluid, and wherein the second reservoiraffects a larger volume of hydraulic fluid in a third reservoir, thethird reservoir being part of a second closed system having largervolume than said first reservoir, thereby creating a movement of alarger total volume of hydraulic fluid with less force per area unit.The apparatus of the discussed embodiment can comprise a wireless remotecontrol, wherein the volume filling device, when implanted in thepatient, is non-invasively regulated by the wireless remote control. Theapparatus of the discussed embodiment can further comprise an energysource that powers the adjustable volume filling device when implantedin a patient. The energy source preferably comprises an internal energysource implantable in the patient. The energy source can also comprisean external energy source transmitting wireless energy. The internalenergy source, when implanted in the patient can be chargeable by thewireless energy transmitted by the external energy source. The wirelessremote control can comprise at least one external signal transmitter andreceiver, further comprising an internal signal receiver and transmitterimplantable in the patient for receiving signals transmitted by theexternal signal transmitter and sending feedback signals back to theremote control. The wireless control signal can comprise an electric ormagnetic field, or a combined electric and magnetic field.

In one embodiment, the apparatus comprises a wireless energy transmitterfor non-invasively energizing any part of the apparatus in need ofenergy supplementation. The energy transmitter preferably transmitsenergy by at least one wireless energy signal. Preferably, the wirelessenergy comprises a wave signal or a field, or the wireless energy signalcan comprise an electric or magnetic field, or a combined electric andmagnetic field. The wave signal preferably is selected from the groupconsisting of: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. The apparatus of this embodiment can further comprisean implantable accumulator and an energy transforming devicetransforming wireless energy to electric energy, wherein the electricenergy is used at least partly to charge the accumulator or to run anyenergy consuming part of the apparatus direct from the energytransforming device.

In one embodiment, the apparatus comprises a sensor sensing a parameter,a functional parameter or a physical parameter of the patient. Thefunctional parameter is correlated to a wireless transfer of energy forcharging an internal energy source implantable in the patient. Theapparatus can further comprise a feedback device that, when implanted inthe patient, sends feedback information from inside the patient's bodyto the outside thereof, the feedback information being related to thefunctional parameter. The apparatus can also comprise an implantableinternal control unit for controlling the volume filling device inresponse to the sensor sensing the functional parameter. The sensor forsensing the physical parameter is a pressure sensor or a motilitysensor. An implantable internal control unit can control o the volumefilling device of the apparatus in response to the sensor sensing thephysical parameter.

In one embodiment, the apparatus comprises an operation device foroperating the volume filling device in order to control its size and/orshape. For this purpose, the operation device can comprise a motor or apump.

In one embodiment of the apparatus, the volume filling device is adaptedto further receive wireless energy, wherein the wireless energy is usedto power the operation device to create kinetic energy for the operationof the volume filling device. The wireless energy can for example beused to directly power the operation device to create kinetic energy forthe operation of the volume filling device, as the wireless energy isbeing transmitted by the energy-transmission device. The volume fillingdeice may also be adapted to receive energy from an energy transformingdevice directly during wireless energy transfer or from an energyaccumulator, being rechargeable by the wireless energy and energytransforming device. The wireless energy, preferably comprises a wavesignal that is selected from the group consisting of: a sound wavesignal, an ultrasound wave signal, an electromagnetic wave signal, aninfrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal and a gamma radiation signal. The wirelessenergy signal can also comprise an electric or magnetic field, or acombined electric and magnetic field.

In one embodiment of the apparatus it further comprises implantableelectrical components including at least one voltage level guard, or atleast one constant current guard.

In general terms any applicable feature or embodiment or part ofembodiment or method described herein are, when applicable, valid forboth the assembled volume filling device as well as for the volumefilling device segments.

It is understood that a skilled person is in the position of combiningsteps, changing the order of steps, and combining elements of thedifferent embodiments of the invention without inventive effort, andwithout departing from the scope of the invention as defined in thedescription and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 is an overall view of a patient showing the outlines of thestomach,

FIG. 2 a is a view of a first embodiment of an apparatus for treatingobesity implanted in a human patient,

FIG. 2 b is a sectional view taken along line IIb-IIb of FIG. 2 a,

FIGS. 3 a-k, 3 m, 3 n, 3 p show different shapes and features of avolume filling device comprised in an apparatus according to theinvention,

FIGS. 4 a-d show a deflated inflatable volume filling device comprisedin an apparatus according to the invention and an instrument for placingthe volume filling device.

FIGS. 5 a-i illustrate different steps of invaginating the inflatabledevice of FIG. 4 a on the outside of a stomach wall of a patient,

FIGS. 6 a-b , 7-8 show alternative embodiments wherein the volumefilling device is adapted to be non-invasively adjustablepostoperatively,

FIGS. 9 and 10 show embodiments wherein the volume filling device isadapted to be invaginated in the fundus region of the patient's stomach,

FIG. 11 shows an embodiment wherein the volume filling device is alsoadapted to treat reflux,

FIG. 12 show an embodiment wherein the volume filling device adaptedalso for treating reflux is combined with stretching devices forstretching part of the stomach fundus wall,

FIGS. 13-16 show alternative embodiments wherein a combination of avolume filling device and a stretching device is used,

FIGS. 17 a and 17 b show an embodiment wherein the volume filling deviceis provided on the inside of the stomach wall,

FIGS. 18 a-h illustrate different steps of invaginating the inflatabledevice of FIG. 4 a on the inside of a stomach wall of a patient,

FIGS. 19 a-j illustrate different steps of invaginating the inflatabledevice of FIG. 4 a on the inside of a stomach wall of a patient,

FIGS. 20 a-f illustrate different steps of invaginating the inflatabledevice of FIG. 4 a on the inside of a stomach wall of a patient,

FIGS. 21 a and 21 b show instruments for surgically applying theimplantable apparatus.

FIG. 22 is an overall view of a patient with an implanted apparatus fortreating obesity,

FIGS. 23-41 show various ways of powering an apparatus for treatingobesity implanted in a human patient,

FIGS. 42-46, 47 a-c show various ways of arranging hydraulic orpneumatic powering of an apparatus for treating obesity implanted in ahuman patient,

FIG. 48 illustrate the invagination of a plurality volume fillingdevices, and

FIGS. 49 a and 49 b illustrate an abdominal method.

FIG. 50 shows an embodiment of the volume filling device in segmentsbefore assembly.

FIG. 51 shows an embodiment of the volume filling device when first partand second part are assembled.

FIG. 52 shows the embodiment of FIG. 51 when a third and a fourth partare assembled.

FIG. 53 shows the embodiment of FIG. 52 when assembling the final part.

FIG. 54 shows the embodiment of FIGS. 50-53 then finally assembled.

FIG. 55 a shows the core part of the embodiment of FIG. 50 with theoperation channels.

FIGS. 55 b to 55 f show crossectional views of the core part of FIG. 55a according to planes I-I; II-II, III-III, IV-IV, respectively.

FIGS. 56 and 57 show different embodiments of the volume filling devicesegments.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the invention will now be described in detailwith reference to the drawing figures.

FIG. 1 shows a human patent 1, who is being treated for obesity. Avolume filling device 10 is provided so that it reduces the inner volumeof the stomach 12—the food cavity of the stomach, thereby affecting thepatient's appetite. The function and the operation of this volumefilling device will be described and explained in detail in thefollowing description.

FIGS. 2 a and 2 b show in detail a first embodiment of an apparatus totreat obesity according to the invention, wherein FIG. 2 a show a sideview of the stomach while FIG. 2 b is a sectional view taken along lineIIb-IIb of FIG. 2 a . The apparatus comprises a volume filling device 10implanted in a human patient. More specifically, in the embodiment ofFIG. 2 a the volume filling device 10 is invaginated in the wall 12 a ofthe patient's stomach 12 on the outside of the stomach wall. The body ofthe volume filling device 10 is elongated and shaped to rest against thewall 12 a of the stomach 12 and further has an outer surface suitable torest against this wall.

By invaginating the volume filling device 10 in part of the stomachwall, the size of the food cavity, generally designated 12 b in FIG. 2 b, will be reduced, resulting in a more rapid feeling of satiety afterfood intake.

The volume filling device 10 preferably comprises an elastic material,such as silicone. In this way, the volume filling device can adapt tothe movements of the stomach, the degree of food intake etc.

By providing the volume filling device from a bio-compatible material,the risk of the patient's body rejecting the implant is to a very largeextent reduced.

The volume filling device 10 can be fixed to the wall 12 a of thestomach 12 in a number of different ways. In the embodiment shown inFIG. 2 b , the volume filling device 10 is invaginated in the stomachwall 12 a. After invagination, a number of stomach-to-stomach sutures orstaples 14 are applied to keep the invagination in the short term. Thisallows growth of human tissue, keeping the invagination in the longterm.

The volume filling device 10 preferably has an essentially round shapeto not damage the stomach wall. An example thereof is shown in FIG. 3 a, wherein the volume filling device is essentially egg-shaped. Inanother preferred embodiment, the volume filling device is slightlybent, such as the embodiment shown in FIG. 3 b . However, since thestomach wall is strong many different shapes, forms, and dimensions maybe used. In one embodiment, the volume filling device has a diameter ofabout 40 millimeters and a length of about 120 millimeters, resulting ina volume that is about half the volume of the patient's stomach.However, it is preferred that the maximum circumference of the volumefilling device is at least 30 millimeters, more preferably at least 50millimeters, and even more preferably at least 80 millimeters.

It is not necessary that the volume filling device is elongated. In theembodiment shown in FIG. 3 c , the volume filling device 10 isessentially spherical or ball-shaped. In order to fill out the stomach,two or more such volume filling devices may be combined to achieve thedesired decrease of the food cavity of the patient's stomach.

It has been mentioned that the volume filling device is secured by thestomach-to-stomach sutures or staples. In order to further improve thefixation, the volume filling device may be provided with a waist portionhaving smaller diameter that the maximum diameter of the volume fillingdevice. Such volume filling device having a waist portion 10 a is shownin FIG. 3 d.

The volume filling device 10 may consist of at least twointerconnectable portions so that each portion is easier to insert intothe stomach and further through a hole in the stomach wall. Thus, FIG. 3e shows a volume filling device comprising two more or less sphericalsub-parts 10 b, 10 c interconnected by a portion with which preferablyhas smaller diameter. The portion with smaller diameter may comprise aninterconnection means with a reversible function allowing subsequentdisconnection of the two interconnected sub-parts 10 b, 10 c. Such meansmay comprise a bayonet socket, a screw connection or the like,designated 10 d in the figure. Alternatively, the portion with smallerdiameter may comprise a fixed interconnection, such as resilient lockinghooks provided on one of the sub-parts 10 b, 10 c and engaging the rimof a hole provided in the other one of the sub-parts 10 b, 10 c.

The configuration of the volume filling device 10 is not limited to onewaist portion 10 a. Thus, in FIG. 3 f a volume filling device with twowaist portions is shown.

In order to facilitate positioning of the volume filling device, anattachment means in the form of a handle or the like may be provided onthe outer surface of the volume filling device. One example thereof isshown in FIG. 3 g , wherein also a detail view of a handle 10 e isshown. In a preferred embodiment, the attachment means is provide at anend portion of the volume filling device 10. In order to avoidprotruding portion on the surface of the volume filling device 10, thehandle 10 e is provided flush with the outer surface of the volumefilling device 10 and a recess 10 f is arranged to allow a gripping toolor instrument (not shown in FIG. 3 g ) to achieve firm gripping aroundthe handle 10 e.

The volume filling device may comprise a tube for filling or emptyingthe volume filling device of a fluid or gel. By injecting fluid or gelinto the volume filling device 10, the volume filling device is inflatedto an inflated state, as will be described below. The size of the volumefilling device can also be adjusted by moving fluid or gel therefrom toa different reservoir.

A volume filling device 10 adapted for this is shown in FIG. 3 h . Atube 10 g is fixedly attached to the volume filling device. This tubecan be attached to a suitable instrument (not shown) or an injectionport, which will be explained in detail below.

Instead of having a fixedly attached tube, the volume filling device 10may comprise an inlet port 10 h adapted for connection of a separatetube (not shown in this figure).

It is important that the implanted volume filling device is firmly keptin place in the stomach wall in which it is invaginated. To this end,the volume filling device can be provided with one or more through holesadapted for receiving sutures or staples used for fixation of theinvagination. Such an embodiment is shown in FIG. 3 j , where the volumefilling device 10 is provided with a row of holes 10 i provided on aprotruding flange-like protrusion on the volume filling device. In thisembodiment, the row of holes extend along the longitudinal axis of thevolume filling device.

FIG. 3 k illustrates how sutures 14 are provided so that they runthrough the stomach wall 12 a and through the holes 10 i. In this way,the volume filling device is fixed in place in the pouch created fromthe stomach wall and will thus be prevented from sliding.

Although a plurality of holes is illustrated in the FIG. 3 j , it willbe appreciated that one single hole is sufficient to obtain improvedfixation of the volume filling device 10.

FIG. 3 m illustrates a volume filling device provided with an inlet port10 h. The volume filling device is invaginated in the stomach wall andthe inlet port 10 h is available for connection to a tube or the likefrom the abdominal area of the patient.

FIG. 3 n illustrates an invaginated volume filling device wherein,instead of an inlet port, a fixed tube 10 g extends into the abdominalarea of the patient.

FIG. 3 p is a figure similar to FIG. 3 m but also illustrating tunnelingof a connection tube 10 g in the stomach wall between the inlet port 10h and the volume filling device 10.

It has been shown that the shape of the volume filling device can takemany different forms. It will be appreciated that also the material ofthe volume filling device can vary. It is preferred that the volumefilling device is provided with a coating, such as a Parylene,polytetrafluoroethylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the volume fillingdevice, such as its resistance to wear.

In one embodiment, the volume filling device comprises an inflatabledevice expandable to an expanded state. In this case, the inflatabledevice is provided with an inlet port for a fluid and is adapted to beconnected to a gastroscopic instrument. This embodiment will now bedescribed in detail with reference to FIGS. 4 a -4 d.

An inflatable volume filling device in its non-expanded state is shownin FIG. 4 a . It is essentially a balloon-like, deflated device 10having an inlet port 10 h. In this state, the inflatable device has adiameter of a few millimeters at the most, allowing it to be insertedinto the stomach through the esophagus of the patient by means of agastroscopic, tube-like instrument 600, depicted in FIG. 4 b . Theinstrument comprises an outer sleeve 600 a and an inner sleeve 600 bwhich can be displaced longitudinally relatively to the outer sleeve.The inner sleeve is provided with a cutter in the form of a cutting edge615 at the distal end thereof. This cutting edge can be used for cuttinga hole in the stomach wall, as will be explained in detail in thefollowing.

When the instrument reaches a stomach wall, see FIG. 4 c , the innersleeve is brought forward from its position in the outer sleeve and intocontact with the stomach wall 12 a. The cutting edge 615 of the innersleeve then cuts a hole in the stomach wall so as to allow subsequentinsertion of the volume filling device 10 into and through this hole,see FIG. 4 d . In order to push the volume filling device through thehole, a piston 602 may be provided in the instrument. Thus, theinstrument further comprises a piston 602 adapted for pushing a deflatedvolume filling device 10 out from a position in the inner sleeve, thisposition being shown in FIG. 4 b , to a position outside of the innersleeve, this being shown in FIG. 4 d.

In order to protect the deflated volume filling device 10 from thecutting edge 615 of the inner sleeve, a further protective sleeve (notshown) can be provided around the volume filling device.

An intraluminar method of invaginating a volume filling device 10 on theoutside of the stomach wall 12 a will now be described with reference toFIGS. 5 a-i . Initially, an instrument 600, preferably a gastroscopicinstrument, is inserted into the mouth of the patient, see FIG. 5 a .The instrument comprises an injection device 601, 602 for injectingeither fluid or a device into the stomach of the patient. The instrument600 further comprises a control unit 606 adapted for controlling theoperation of the instrument. To this end, the control unit 606 comprisesone or more steering devices, in the embodiment shown in the figure inthe form of two joysticks 603 and two control buttons 604. A display 605is provided for displaying the image provided by an optical device forviewing inside the stomach, such as a camera (not shown) arranged at theouter end of the elongated member 607, see FIGS. 5 e-i . The camera,which may comprise connecting electrical wires extending along theelongated member, may be assisted by a light source (not shown) placeddistally on the elongated member for illuminating the inside of thestomach. The optical device may also comprise optical fibers placedalong the elongated member and leading out from the patient's body forexternal viewing of the inside of the stomach.

The instrument is further inserted into the esophagus and into thestomach of the patient, see FIG. 5 b . By means of the instrument 600, ahole 12 b is created in the wall of the stomach 12. To this end, theinstrument is provided with one or more cutters 615 at the distal endthereof, for example in the way described above with reference to FIGS.4 a-d . These cutters can of course be designed in different ways, suchas a toothed drum cutter rotating about the center axis of the tube-likeinstrument.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 12 b so that itends up outside the stomach wall 12 a. This is shown in FIG. 5 c ,showing a side view of the stomach 12, and FIG. 5 d , which is asectional view through the stomach of FIG. 5 c taken along the linesVd-Vd.

The instrument 600 is adapted to create a “pocket” or “pouch” on theoutside of the stomach 12 around the hole 12 b in the stomach wall. Suchan instrument and the method of providing the pouch will now bedescribed.

FIGS. 5 e-i show a gastroscopic or laparoscopic instrument forinvaginating a volume filling device 10 in the stomach wall 12 a of thepatient by creating a pouch of stomach wall 12 a material in which thevolume filling device is placed. The instrument, generally designated600, and which may comprise the features described above with referenceto FIGS. 4 a-d , comprises an elongated member 607 having a proximal endand a distal end, the elongated member 607 having a diameter less thanthat of the patient's esophagus and being flexible such as to allowintroduction of the flexible elongated member 607 with its distal endfirst through the patient's throat, esophagus and into the stomach 12 tothe stomach wall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the volume filling device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the volume filling device will now bedescribed in detail. After the instrument 600 has been inserted into thestomach 12, the stomach penetration device 615 is placed into contactwith the stomach wall 12 a, see FIG. 5 e . The stomach penetrationdevice or cutter 615 is then brought to create the hole 12 b in thestomach wall, whereafter at least the expandable member 611 is broughtthrough the hole 12 b in the stomach wall. The special holding device609 is in this step brought to a holding state wherein it expandsradially so as to form an essentially circular abutment surface to thestomach wall 12 a, see FIG. 5 f . In this way, the insertion of thestomach penetration device 615 and the expandable member 611 through thehole 12 a in the stomach wall is limited to the position shown in FIG. 5f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then refracted in the proximal direction, as indicated by thearrow in FIG. 5 g , thereby pulling the stomach wall 612 into a basketor cup like structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 5 h , an inflatable volumefilling device 10 is placed in its deflated state in the cup likestructure. The volume filling device 10 is then inflated to its inflatedor expanded state, see FIG. 5 i . This inflation of the volume fillingdevice 10 can be accomplished by injecting a fluid or a gel into thedeflated volume filling device. It can also be accomplished by injectinga material which is allowed to cure, thereby forming a solid device 10.Thus, the volume filling device 10 shown in FIGS. 5 h and 5 i canillustrate either a balloon-like device which is subsequently filledwith fluid or gel or alternatively a material which is simply injectedinto the cup like structure formed by the stomach wall 12 a.

The fluid which is used to fill the volume filling device 10 could beany suitable fluid suitable to fill the inflatable device 10, such as asalt solution. In another embodiment, when this fluid is a fluid whichis adapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic, i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples are preferably provided withfixation portions exhibiting a structure, such as a net like structure,adapted to be in contact with the stomach wall to promote growth in ofhuman tissue to secure the long term placement of the volume fillingdevice attached to the stomach wall.

After the inflatable device 10 has been inflated, partly or fully, theinlet port 10 b (not shown in FIGS. 5 h and 5 i ) of the volume fillingdevice 10, is sealed and the instrument 600 is retracted from the hole12 b, which is subsequently closed in some suitable way, such as bymeans of the instrument 600. The instrument is then removed from thestomach 600 and the inflatable device 10 in its inflated or expandedstate is invaginated by a stomach wall portion of the patient on theoutside of the stomach wall. This reduces the inner volume of thestomach, thereby affecting the patent's appetite.

During one or more of the above described steps, the stomach may beinflated with gas, preferably by means of the gastroscopic instrument.

The volume filling device 10 described above with reference to FIGS. 5a-i has been described as an inflatable volume filling device. It willbe appreciated that is also can be an elastic volume filling device withan elasticity allowing compression so as to be inserted into agastroscopic instrument and which expands to an expanded state afterleaving the instrument.

An alternative embodiment of an apparatus for treating obesity will nowbe described with reference to FIGS. 6 a and 6 b , showing a sectionalview of a stomach in which a volume filling device is invaginated in thestomach wall on the outside thereof together with a system forregulating the size of the volume filling device. The volume fillingdevice is an inflatable device as described above with reference toFIGS. 5 a-h and thus comprises a fluid. The inflatable device 10 thusforms a fluid chamber, in which fluid is allowed to flow. The inflatabledevice thereby forms an expandable chamber that can change the volume itoccupies in the stomach wall, thereby forming a hydraulically orpneumatically regulated inflatable device.

In FIG. 6 a , an injection port 16 for fluids is connected to theinflatable volume filling device 10 by means of a conduit 18 in the formof a tube. The inflatable device 10 is thereby adapted to be regulated,preferably non-invasively, by moving liquid or air from the injectionport 16 to the chamber formed by the inflatable device. By using ahypodermic needle or the like, the amount of fluid in the inflatabledevice 10 can thus be adjusted, thereby adjusting the size of theadjustable device. The injection port 16 can also be used simply forrefilling the volume filling device 10.

The regulation reservoir 17 can be regulated in several ways. In analternative embodiment, the regulation reservoir 17 is regulated bymanually pressing a regulation reservoir. In other words, the regulationreservoir is regulated by moving a wall of the reservoir. It is thenpreferred that the regulation reservoir is placed subcutaneously andnon-invasive regulation is thereby achieved.

A similar embodiment is shown in FIG. 6 b . However, in this embodimentthe injection port 16 has been replaced by an adjustable regulationreservoir 17 in fluid connecting with the volume filling device 10 via atube 18. When the regulation reservoir 17 is pressed, the volume thereofdecreases and hydraulic fluid is moved from the reservoir to the chamberformed by the inflatable device 10 via the conduit or tube 18, enlargingor expanding the inflatable device 10. In this way, the volume fillingdevice is non-invasively adjustable postoperatively.

It will be appreciated that instead of hydraulic operation, pneumaticoperation can be used, wherein air instead of hydraulic fluid is movedbetween the regulation reservoir and the chamber formed by theinflatable device 10. Preferable the regulation reservoir has a lockingposition to keep it in the desired position. If the patient compressesthe reservoir it preferably stays compressed and releases after pressingagain.

Any kind of hydraulic solution may be used for the inflatable device.The hydraulic solution may be driven by both mechanically and be poweredwith any motor or pump as well as manually.

In another embodiment, shown in FIG. 7 , a motor 40 is adapted to move awall of the regulation reservoir 17. The powered regulation reservoir 17is then preferably placed in the abdomen of the patient. In thisembodiment, a wireless external remote control unit forming part of theexternal energy transmission device 34 can be provided to performnon-invasive regulation of the motor via an energy transforming device30, which is adapted to supply an energy consuming operation device, inthe present example the motor 40, with energy via a power supply line32.

The remote control may comprise a wireless energy transmitter, wherebythe non-invasive regulation is performed by the energy transmitter. Whenthe regulation is performed by means of a remote control an internalpower source for powering the regulating device is provided. Theinternal energy source can for example be a chargeable implanted batteryor a capacitor or a device for receiving wireless energy transmittedfrom outside the body of the patient. Different ways of regulating theinflatable device 10 will be described below with reference to FIGS.22-41 .

In yet an alternative embodiment, shown in FIG. 8 , the apparatus fortreating obesity comprises a pump 44, wherein the reservoir is regulatedby the pump 44 pumping fluid or air from the reservoir to the chamberformed by the inflatable device. Different configurations of this pumpwill be described below with reference to FIGS. 22-41 .

Yet an alternative embodiment of an apparatus for treating obesity willnow be described with reference to FIG. 9 , which shows a stomach 12 ofa patient who is treated for obesity. This embodiment is similar to theone described above with reference to FIG. 7 and the apparatus comprisesa volume filling device in the form of an inflatable device 10 which isinvaginated in the wall 12 a of the patient's stomach 12. However, inthis case the invagination has been performed in the fundus, i.e., theupper portion of the stomach, where the number of receptors in thestomach wall is large, and the inflatable device functions as astretching device for part of the stomach fundus wall.

A regulation reservoir 17 for fluids is connected to the inflatabledevice by means of a conduit 18 in the form of a tube. The inflatabledevice 10 is thereby adapted to be regulated, preferably non-invasively,by moving liquid or air from the regulation reservoir 17 to the chamberformed by the inflatable device 10. The regulation of the inflatabledevice 10 preferably comprises a reversed servo, i.e., a small volume isactuated for example by the patient's finger and this small volume is inconnection with a larger volume, i.e., the regulation reservoir 17.

Thus, the inflatable device 10 is placed outside the stomach wall and isadapted to stretch a part of the stomach fundus wall, thereby affectingthe patient's appetite. By enlarging the size of the stretching device,the stomach fundus wall 12 a surrounding the inflatable stretchingdevice 10 is stretched since the circumference of the inflatablestretching device 10 is increased. By this stretching, the receptors inthe stomach wall indicate that the stomach is full, thereby creating afeeling of satiety to the patient. Correspondingly, when the stretchingdevice 10 is contracted, the receptors indicate that the stomach is notfull, thereby returning the feeling of hunger. It will be appreciatedthat this embodiment combines the effects of both reducing the volume ofthe stomach food cavity and stretching part of the stomach wall, therebyincreasing the treatment effect.

The expansion and contraction of the stretching device 10 can beperformed under direct control of the patient. Alternatively, theexpansion and contraction can be performed according to a pre-programmedschedule.

In a preferred embodiment, shown in FIG. 10 , a sensor 19 is provided ata suitable position, such as at the esophagus. The volume filling device10 in the form of the inflatable stretching device is similar to the oneshown in FIG. 9 . By providing one or more sensors, the apparatus fortreating obesity can be automated in that the size of the volume fillingdevice 10 in the form of the inflatable stretching device is adjusteddepending on the amount of food entering the food cavity of the stomach.The fluid is thereby moved between the inflatable volume filling device10 and a fluid reservoir 15.

The apparatus for treating obesity can have the additional functionalityof treating reflux. An embodiment having this function is shown in FIG.11 , wherein the volume filling device 10 is invaginated in the stomachwall close to and at least partially above the patient's cardia 26 whenthe patient is in a standing position and is fixed to a position abovethe cardia area 26 by a fixation, such as sutures or staples 14 a. Forexample a direct or indirect fixation to the diaphragm muscle or othermuscle tissue may be provided. As an alternative a direct or indirectfixation to the esophagus above and close to the angle of His can beprovided. In this alternative embodiment, the volume filling device 10rests in a position against stomach wall of the fundus when implantedand which also fills a volume above the cardia area 26 between thecardia and the diaphragm muscle so that the cardia is prevented fromslipping up into the thorax cavity, whereby reflux disease is prevented.

Such a volume filling device 10 may be used for keeping electronicsand/or an energy source and/or hydraulic fluid. Hydraulic fluid fromthat device may be distributed to several smaller inflatable deviceareas to vary the stretching area from time to time avoiding anypossible more permanent stretching effect of the stomach wall. Evenmechanically several stretching areas may be used.

In an alternative embodiment, which is shown in FIG. 12 , the volume ofan inflatable volume filling device 10 may be in fluid connection withone or more preferably smaller inflatable devices or chambers 50. Thesechambers are adapted to communicate with fluid or air being movedbetween the chambers.

Thus, the large chamber 10 is adapted to, with its main volume to be avolume filling device for reducing the size of the food cavity and fortreating reflux disease and the one or several small chambers areadapted to function as the inflatable devices to treat obesity, whereinthe main chamber is adapted to communicate with fluid or air to thesmall chambers causing a stretching effect in the stomach wall therebyfurther treating obesity.

In FIGS. 13-16 , different embodiments embodying a combination of avolume filling device invaginated in the central or lower portion of thestomach and a stretching device invaginated in the upper portion orfundus of the patient's stomach. Thus, in FIG. 13 there is shown anadjustable volume filling device 10, which is invaginated in the stomachwall of a patient's stomach 12. Additionally, an adjustable stretchingdevice 50 with the previously described function is invaginated in thestomach fundus wall of the patient. It is preferred that the volumefilling device 10 is substantially larger than the stretching device 50.

The volume filling device 10 and the stretching device 50 are in fluidcommunication with each other via a fluid communication devicecomprising a first fluid tube 52, in which a pump 54 is provided. Thepump 54 is under the control from an energy transforming device 30,which is adapted to supply the pump 50 with energy via a power supplyline 56. The energy transforming device 30 is also connected to a sensor19 provided in the esophagus of the patient so that food intake can bedetected.

The volume filling device 10 and the stretching device 50 are also influid communication with each other via a second fluid tube 58, whichpreferably has a smaller cross-sectional area than the first fluid tube52.

The operation of this arrangement is as follows. The volume fillingdevice 10 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12.Additionally, when the stretching device 50 is enlarged by pumping fluidfrom the volume filling device 10 and to the stretching device 50 bymeans of the pump 54, the stomach fundus wall is stretched, creating afeeling of satiety for the patient. Thus, for example when food intakeis detected by means of the sensor 19, fluid is automatically pumpedinto the stretching device 50 to increase the feeling of satiety andthereby limit the food intake.

When fluid has been injected into the stretching device 50, the internalpressure therein is higher than the internal pressure in the volumefilling device 10. This difference in pressure will create a flow offluid in the second, preferably narrower tube 58 from the stretchingdevice 50 to the volume filling device 10. The flow rate will bedetermined by among other things the difference in pressure and thecross-sectional area of the second tube 58. It is preferred that thesecond tube is so dimensioned, that the pressures in the volume fillingdevice 10 and the stretching device 50 will return to equilibrium after3 hours after fluid has been injected into the stretching device 50 tocreate the feeling of satiety.

In this embodiment, the function of the second tube 58 is to allow fluidto return from the stretching device 50 to the volume filling device 10.It will be appreciated that this function also can be performed by thepump 54 in the first tube 52 and that the second tube 58 then can beomitted.

FIG. 14 illustrates an embodiment similar to the one illustrated in FIG.13 . Thus, there is provided an adjustable volume filling device 10,which is invaginated in the stomach wall of a patient's stomach 12.Additionally, an adjustable stretching device 50 with the previouslydescribed function is invaginated in the stomach fundus wall of thepatient. It is preferred that the volume filling device 10 issubstantially larger than the stretching device 50.

The volume filling device 10 and the stretching device 50 are in fluidcommunication with each other via a first fluid tube 52, and a secondfluid tube, which preferably has a smaller cross-sectional area than thefirst tube. However, instead of a pump, there is provided a non-returnvalve 60 in the first fluid tube 52 instead of an energized pump. Thisnon-return valve 60 allows fluid to flow in the direction from thevolume filling device 10 and to the stretching device 10 but not viceverse. This means that this embodiment may be entirely non-energized.Instead, it operates according to the following principles.

When the food cavity of the stomach 12 is essentially empty, there is astate of equilibrium between the internal pressure of the volume fillingdevice 10 and the stretching device 50. In this state, the stretchingdevice is in a non-stretch state, i.e., it does not stretch a part ofthe stomach fundus wall and thus does not create a feeling of satiety.

When the patient starts to eat, food will enter the food cavity of thestomach 12. This will create increased pressure on the stomach wall inwhich the volume filling device 10 is invaginated and the internalpressure therein will increase. Also, the stomach wall muscles willbegin to process the food in the food cavity by contraction, which alsocontributes to an increased internal pressure in the volume fillingdevice 10.

Since the internal pressure in the stretching device 50 will remainessentially unchanged, because it is located in the upper part of thestomach 12 where no food is exerting a pressure on the stomach wall, afluid flow will be created through the first and second fluid tubes 52,58 in the direction from the volume filling device 10 and to thestretching device 50. This in turn will increase the volume of thestretching device 50, which, by stretching the stomach fundus wall, willprovide a feeling of satiety to the patient.

A fluid flow from the stretching device 50 to the volume filling device10 through the second tube 58 will return the pressure of these devicesto equilibrium as described above with reference to FIG. 13 .

FIG. 15 illustrates an embodiment, which is similar to the one shown inFIG. 14 but with the addition of an injection port 16, which is used forrefilling the fluid system comprising the volume filling device 10 andthe stretching device 50 or alternatively for actively adjusting thesize thereof.

Similarly, FIG. 16 illustrates an embodiment wherein the stretchingdevice 50 can be actively regulated by manually pressing an adjustmentreservoir which is provided subcutaneously below the patient's skin,similar to the embodiment shown in FIG. 9 . Thus, a regulation reservoir17 for fluids is connected to the inflatable device by means of aconduit 18 in the form of a tube. The stretching device 50 is therebyadapted to be regulated, non-invasively, by moving liquid or air fromthe regulation reservoir 17 to the chamber formed by the inflatabledevice. The regulation of the stretching device 50 preferably comprisesa reversed servo, i.e., a small volume is actuated for example by thepatient's finger and this small volume is in connection with a largervolume.

An alternative placement of the volume filling device 10 is shown inFIGS. 17 a and 17 b , wherein FIG. 17 b shows a sectional view throughthe stomach shown in FIG. 17 a along the line XVIIb-XVIIb. There, thevolume filling device 10 is adapted to be placed inside the wall of thestomach 12, such as via a gastroscope or similar intraluminarinstrument, and resting against the inside of the stomach wall 12 a. Theinflatable device can be kept invaginated by means of sutures or staples14, like in the embodiment of FIGS. 2 a and 2 b . In this embodiment, nohole is required in the stomach wall. Instead, a method of providing thevolume filling device 10 can comprise the following steps, which will beexplained with reference to FIGS. 18 a-i showing an invaginationinstrument

The invagination instrument, generally designated 630, comprises anelongated tube member 632 similar to the elongated member 607 describedabove with reference to FIGS. 5 a-i . Thus, it can be connected to acontrol unit 606, see FIG. 5 a . The invagination instrument 630 furthercomprises a perforated suction portion 634, which preferably iselongated. The suction portion 634 exhibits a plurality of small holes636, into which air will be sucked by providing suction in the tubemember 632. This suction effect will be used to create a “pocket” or“pouch” in a part of a stomach wall, generally designated 12 a.

In other words, when the tip of the suction portion 634 is pressedagainst the stomach wall 12 a, see FIG. 18 a , a small recess will beformed therein. When the suction portion 634 is further pressed againstthe stomach wall 12 a, see FIG. 18 b , a larger recess will be formed.The part of the stomach wall 12 a that forms the recess will, due to thesuction effect, adhere to the suction portion 634 of the invaginationinstrument 630. As the suction portion 634 is further pressed into thestomach wall 12 a, see FIG. 18 c , a deeper recess will be formed untilthe entire suction portion 634 is embedded in the recess, see FIG. 18 d.

The rim of the recess will at this stage be fixated by means of fixationelements 638 and the suction portion be removed from the instrument, seeFIG. 18 e . A compressed elastic volume filling device 10 willsubsequently be inserted into the recess, see FIG. 18 f , for example inthe way described above with reference to FIG. 4 d . This compressedvolume filling device is then expanded to its final shape, see FIG. 18 g, where after the pouch is sealed by suturing or stapling by means ofthe fixations elements, see FIG. 18 h.

All the alternatives described above with reference to FIGS. 2-16 arealso applicable to the embodiment described with reference to FIGS. 17and 18 , i.e., to the embodiment where the volume filling device isinvaginated on the inside of the stomach wall.

FIGS. 19 a-j show an instrument for use in a method of engaging a volumefilling device 10 to the stomach wall 12 of a patient. The instrument isadapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 650 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 650 is adapted to be flexible bymeans of said elongated member 650 being made of a flexible oradjustable material. The elongated member 650 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 650 has a specialholding device 651 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding device 651 comprises afirst joint 652 and a second joint 653, which enable the special holdingdevice 651 be operable in relation to the elongated member 650 andthereby place the part of the holding device 651 comprising themechanical grabbing members or vacuum elements into contact with thestomach wall 12 of the patient. FIG. 19 b shows the special holdingdevice 651 when placed in contact with the stomach wall 12 of the humanpatient, after which the special holding member 651 connects to thestomach wall 12, for holding the stomach wall 12. FIG. 19 c shows theinstrument when the step of advancing a pushing rod 654 from theelongated member 650 is performed. The pushing rod 654 pushes thestomach wall 12 to create a cavity or pouch thereof. FIG. 19 d shows theinstrument turned 90° in relation to FIGS. 19 a-c . This view shows thespecial holding members 651 a,b operably attached to two sides of theelongated member 650 and being in contact with the stomach wall 12,holding the stomach wall 12 as the pushing rod 654 pushes to create acavity or pouch. When the pushing rod 654 has pushed the stomach wall 12to a desired position the special holding devices 651 a,b moves towardsthe pushing rod 654 and thereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.19 f shows the advancement of a suturing or stapling device 655 from theelongated member 650. The suturing or stapling device 655 is positionedin connection with the stomach wall after which the suturing or staplingdevice commences with the suturing or stapling of the stomach wall 12,creating a seal of stomach to stomach sutures or staples 14. Theinstrument is moved along the stomach wall 12 of the patient and therebya cavity or pouch is created and sealed using the instrument, as shownin FIGS. 19 g and 19 h . When a cavity or pouch or desired size has beencreated and sealed an inserting member 656 is advanced from theelongated member 650. The inserting member 656 is adapted to insert avolume filling device 10 being inflatable, as described earlier in thisapplication. After the inserting member 656 has been positioned in thecavity or pouch the volume filling device 10 is inserted through theinserting member 656 and into the cavity or pouch by means of apressurized fluid or gas, or a mechanical advancement member pushingsaid inflatable volume filling device 10 into the cavity or pouch. Theinsertion member then inflates the inflatable volume filling device witha fluid or gas and seals of the final section of the pouch using stomachto stomach sutures or staples 14. The embodiment described explains theprocess of inserting an inflatable volume filling device, however it isequally conceivable that the volume filling device 10 is expandable bymeans of the volume filling device 10 being made of an elastic material.

FIGS. 20 a-f show an instrument for use in a method of engaging a volumefilling device 10 to the stomach wall 12 of a patient. The instrument isadapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 660 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 660 is adapted to be flexible bymeans of said elongated member 660 being made of a flexible oradjustable material. The elongated member 660 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 660 has multiple specialholding devices 661 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding devices 661 are lockedin a position alongside the elongated member 660 by means of a lockingring 662. The special holding devices are made of a flexible materialend pre-bent to expand into a funnel-shaped device when said lockingring 662 is removed. The special holding device in its funnel shapedexpandable state is shown in FIG. 20 b . FIG. 20 b further shows thespecial holding device 661 when placed in contact with the stomach wall12 of the human patient, after which the special holding member 661connects to the stomach wall 12, for holding the stomach wall 12. FIG.20 c shows the instrument when the step of advancing a pushing rod 664from the elongated member 660 is performed. The pushing rod 664 pushesthe stomach wall 12 to create a cavity or pouch thereof. When thepushing rod 664 has pushed the stomach wall 12 to a desired position thespecial holding devices 661 moves towards the pushing rod 664 andthereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.20 d shows the advancement of a suturing or stapling device 665 from theelongated member 660. The suturing or stapling device 665 is positionedin connection with the stomach wall 12 after which the suturing orstapling device 665 commences with the suturing or stapling of thestomach wall 12, creating a seal of stomach to stomach sutures orstaples 14. Thereafter an inserting member 666 is advanced from theelongated member 660 and the special holding devices 661 are retracted.The inserting member 666 is adapted to insert a volume filling device 10being inflatable, as described earlier in this application. After theinserting member 666 has been positioned in the cavity or pouch thevolume filling device 10 is inserted through the inserting member 666and into the cavity or pouch by means of a pressurized fluid or gas, ora mechanical advancement member pushing said inflatable volume fillingdevice 10 into the cavity or pouch. The insertion member 656 theninflates the inflatable volume filling device with a fluid or gas andseals of the final section of the pouch using stomach to stomach suturesor staples 14. The embodiment described explains the process ofinserting an inflatable volume filling device 10, however it is equallyconceivable that the volume filling device 10 is expandable by means ofthe volume filling device 10 being made of an elastic material. FIG. 20f shows the volume filling device 10 as the volume filling device 10 isinvaginated in the stomach wall 12, in a cavity or pouch sealed withstomach to stomach sutures or staples 14.

FIG. 21 a shows an instrument used in a method of engaging the volumefilling device according to any of the embodiments of the application tothe stomach wall 12. The instrument comprises an elongated member 670which is adapted to be flexible by means of a construction comprisingmultiple ring shaped members, however it is equally conceivable thatsaid elongated member 670 is adapted to be flexible by means of saidelongated member 670 being made of a flexible or adjustable material.The elongated member 670 is inserted into the body and placed inproximity to the stomach wall 12 of the patient, from the insidethereof. A stomach penetrating member 672 is placed in the distal end ofthe elongated member 670, retractably fixated to a protective sleeve 673adapted to protect the tissue of the body from the sharp penetratingmember 672 or cutter 672 after the cutting operation has been performed.

FIG. 21 b shows the instrument comprising the elongated member 670 afterthe cutting operation has been performed and the stomach penetratingmember or cutter 672 has been retracted into the protective sleeve 673.A guiding wire 671 is pushed through the elongated member 670, throughthe hole made in the stomach wall 12 and out through the abdomen andplaced on the inside of the patients skin, which is penetrated from theoutside to enable the guiding wire 671 to exit the abdomen. The guidingwire 671 can then be used to guide a conduit 18 or a lead attached tothe volume filling device 10 being placed in the stomach from the insidethereof. The volume filling device 10 with the conduit 18 or electricallead being a volume filling device 10 according to any of theembodiments of this application. The guiding of the conduit 18 orelectrical lead enables the attachment of the conduit 18 or electricallead to a control unit 42 placed subcutaneously in the patient from theoutside of the abdomen.

FIGS. 20 a-f show an instrument for use in a method of engaging a volumefilling device 10 to the stomach wall 12 of a patient. The instrument isadapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 660 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 660 is adapted to be flexible bymeans of said elongated member 660 being made of a flexible oradjustable material. The elongated member 660 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 660 has multiple specialholding devices 661 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding devices 661 are lockedin a position alongside the elongated member 660 by means of a lockingring 662. The special holding devices are made of a flexible materialend pre-bent to expand into a funnel-shaped device when said lockingring 662 is removed. The special holding device in its funnel shapedexpandable state is shown in FIG. 20 b . FIG. 20 b further shows thespecial holding device 661 when placed in contact with the stomach wall12 of the human patient, after which the special holding member 661connects to the stomach wall 12, for holding the stomach wall 12. FIG.20 c shows the instrument when the step of advancing a pushing rod 664from the elongated member 660 is performed. The pushing rod 664 pushesthe stomach wall 12 to create a cavity or pouch thereof. When thepushing rod 664 has pushed the stomach wall 12 to a desired position thespecial holding devices 661 moves towards the pushing rod 664 andthereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.20 d shows the advancement of a suturing or stapling device 665 from theelongated member 660. The suturing or stapling device 665 is positionedin connection with the stomach wall 12 after which the suturing orstapling device 665 commences with the suturing or stapling of thestomach wall 12, creating a seal of stomach to stomach sutures orstaples 14. Thereafter an inserting member 666 is advanced from theelongated member 660 and the special holding devices 661 are retracted.The inserting member 666 is adapted to insert a volume filling device 10being inflatable, as described earlier in this application. After theinserting member 666 has been positioned in the cavity or pouch thevolume filling device 10 is inserted through the inserting member 666and into the cavity or pouch by means of a pressurized fluid or gas, ora mechanical advancement member pushing said inflatable volume fillingdevice 10 into the cavity or pouch. The insertion member 656 theninflates the inflatable volume filling device with a fluid or gas andseals of the final section of the pouch using stomach to stomach suturesor staples 14. The embodiment described explains the process ofinserting an inflatable volume filling device 10, however it is equallyconceivable that the volume filling device 10 is expandable by means ofthe volume filling device 10 being made of an elastic material. FIG. 20f shows the volume filling device 10 as the volume filling device 10 isinvaginated in the stomach wall 12, in a cavity or pouch sealed withstomach to stomach sutures or staples 14.

FIG. 21 a shows an instrument used in a method of engaging the volumefilling device according to any of the embodiments of the application tothe stomach wall 12. The instrument comprises an elongated member 670which is adapted to be flexible by means of a construction comprisingmultiple ring shaped members, however it is equally conceivable thatsaid elongated member 670 is adapted to be flexible by means of saidelongated member 670 being made of a flexible or adjustable material.The elongated member 670 is inserted into the body and placed inproximity to the stomach wall 12 of the patient, from the insidethereof. A stomach penetrating member 672 is placed in the distal end ofthe elongated member 670, retractably fixated to a protective sleeve 673adapted to protect the tissue of the body from the sharp penetratingmember 672 or cutter 672 after the cutting operation has been performed.

FIG. 21 b shows the instrument comprising the elongated member 670 afterthe cutting operation has been performed and the stomach penetratingmember or cutter 672 has been retracted into the protective sleeve 673.A guiding wire 671 is pushed through the elongated member 670, throughthe hole made in the stomach wall 12 and out through the abdomen andplaced on the inside of the patients skin, which is penetrated from theoutside to enable the guiding wire 671 to exit the abdomen. The guidingwire 671 can then be used to guide a conduit 18 or a lead attached tothe volume filling device 10 being placed in the stomach from the insidethereof. The volume filling device 10 with the conduit 18 or electricallead being a volume filling device 10 according to any of theembodiments of this application. The guiding of the conduit 18 orelectrical lead enables the attachment of the conduit 18 or electricallead to a control unit 42 placed subcutaneously in the patient from theoutside of the abdomen.

FIG. 22 illustrates a system for treating a disease comprising anapparatus 10 comprising a volume filling device of the present inventionplaced in the abdomen of a patient. An implanted energy-transformingdevice 1002 is adapted to supply energy consuming components of theapparatus with energy via a power supply line 1003. An externalenergy-transmission device 1004 for non-invasively energizing theapparatus 10 transmits energy by at least one wireless energy signal.The implanted energy-transforming device 1002 transforms energy from thewireless energy signal into electric energy which is supplied via thepower supply line 1003.

The implanted energy-transforming device 1002 may also comprise othercomponents, such as: a coil for reception and/or transmission of signalsand energy, an antenna for reception and/or transmission of signals, amicrocontroller, a charge control unit, optionally comprising an energystorage, such as a capacitor, one or more sensors, such as temperaturesensor, pressure sensor, position sensor, motion sensor etc., atransceiver, a motor, optionally including a motor controller, a pump,and other parts for controlling the operation of a medical implant.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 23 illustrates the system of FIG. 22 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 24 shows an embodiment of the invention identical to that of FIG.23 , except that a reversing device in the form of an electric switch1006 operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 25 shows an embodiment of the invention identical to that of FIG.23 , except that an operation device 1007 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 1002 and the apparatus 10. This operationdevice can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 26 shows an embodiment of the invention identical to that of FIG.23 , except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 1009 back from the apparatus 10 to the fluidreservoir 1010 to return the apparatus to a starting position. Theimplanted energy-transforming device 1002 transforms wireless energyinto a current, for example a polarized current, for powering themotor/pump unit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 27 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shifting device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the apparatus 10 to operate theapparatus, and another opposite direction in which the fluid is pumpedby the motor/pump unit 1009 back from the apparatus 10 to the hydraulicfluid reservoir 1013 to return the apparatus to a starting position.

FIG. 28 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 10. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming device 1002 via a power line 1020, thecapacitor 1017, which stabilizes the electric current, a power line 1021and the power line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 28 10 may be omitted. In accordance with another alternative,the accumulator 1016 in this embodiment may be omitted.

FIG. 29 shows an embodiment of the invention identical to that of FIG.23 , except that a battery 1022 for supplying energy for the operationof the apparatus 10 and an electric switch 1023 for switching theoperation of the apparatus 10 also are implanted in the patient. Theelectric switch 1023 may be controlled by the remote control and mayalso be operated by the energy supplied by the implantedenergy-transforming device 1002 to switch from an off mode, in which thebattery 1022 is not in use, to an on mode, in which the battery 1022supplies energy for the operation of the apparatus 10.

FIG. 30 shows an embodiment of the invention identical to that of FIG.29 , except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 10.

FIG. 31 shows an embodiment of the invention identical to that of FIG.30 , except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 32 shows an embodiment of the invention identical to that of FIG.31 , except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 33 shows an embodiment of the invention identical to that of FIG.29 , except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the apparatus 10 (mechanically operated). Even simpler isto switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.

FIG. 34 shows an embodiment of the invention identical to that of FIG.40 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the apparatus 10.

FIG. 35 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feedback information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 36 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the apparatus 10 via a subcutaneous electricswitch 1026. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 37 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus. Alternatively, thehydraulic fluid reservoir 1013 is adapted to work with an injection portfor the injection of hydraulic fluid, preferably for calibration ofhydraulic fluid.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 38 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 38 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physical parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 38employs the feedback of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 38 , the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.

This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 38 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 39 , although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 39 ,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 40 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.38 , an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 38 and FIG. 40 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 41 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 41 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 24 ; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 41and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 41 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 24 could be incorporated in any of theembodiments of FIGS. 27-33 , the hydraulic valve shifting device 1014 ofFIG. 27 could be incorporated in the embodiment of FIG. 26 , and thegear box 1024 could be incorporated in the embodiment of FIG. 25 .Please observe that the switch simply could mean any electronic circuitor component.

The embodiments described in connection with FIGS. 38, 40 and 41identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

In one embodiment at least one battery may be a part of or replace theenergy-transforming device 1002 to supply energy to the apparatus 10over a power supply line. In one embodiment the battery is notrechargeable. In an alternative embodiment the battery is rechargeable.The battery supply may of course be placed both remote to andincorporated in the device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 42-45 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 42 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 43 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 44 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 45 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 45 a-c . InFIG. 45 a , a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 45 a , the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 45 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 46 and 47 a-c. The block diagramshown in FIG. 46 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 47 a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 47 a , the servo reservoir 1050 containsa minimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.45 a-c , the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

One single volume filling device has been described as invaginated inthe stomach wall. Alternatively, two or more volume filling devices 10may be invaginated to obtain the desired reduction of the food cavity.One such example is illustrated in FIG. 48 , wherein three ball-shapedvolume filling devices 10 are invaginated in the wall of the patent'sstomach 12.

It has been described how the volume filling device 10 is invaginated inthe stomach wall by means of a gastroscopic instrument. It will beappreciated that abdominal operation methods can be used as well. Suchmethods will now be described in detail with reference to FIGS. 49 a and49 b.

FIG. 50 shows an embodiment of an apparatus according to the invention.FIG. 50 shows the segments of a volume filling device to be assembledbefore implantation in a patient in the need of treatment for a refluxdisease. The volume filling device segments include a core part 560 andfour outer parts 561 a-561 d. The generally cylindrical core part isprovided with an upper part 560′ and is provided with four slits 562a-562 d which are symmetrically distributed end extend along theperipheral outside of the core part, The outer parts 561 a-561 s areshown as generally being a part of sphere having an inner and outersurface and each part is provided with a protruding flange 563 a-563 dextending along the inner surface. The flanges 563 a-563 d matches theslits 562 a-562 d in the depicted embodiment, but can be arranged withloose fits between flanges and slits so the assembled volume fillingdevice sufficiently is assembled at its implanted target position abovethe cardia. If the volume filling device inadvertently is displaced fromthis position to the stomach cavity, a loose fit arrangement contributesto a more rapid disassembly its segments. The core part is connected toa guiding wire 564 which extends through first channel 565 in the corepart through a corresponding channel 565 a between two neighboringorifices in the protrusion 563 a in the first outer part 561 a. Whenoperating on the guiding wire 564 by displacing it away from the corepart upper surface 560′ the first outer part 561 a will be displacedtowards the core part and the flange 563 a meets the slit 562 a so thefirst outer part is assembled to the core part 560. As demonstrated inFIG. 51 , this performance is repeated with the second outer part, nowby the guiding wire 564 through the second channel 566 connected to acorresponding channel in the flange 563 b of second outer part 561 b.FIG. 52 shows this performance again for assembling the third outer part561 c and third channel 567 connecting the guiding wire 564 to flange563 c. FIG. 53 shows the fourth and last outer part 561 d beingassembled through flange 563 d and channel 568. FIG. 54 shows thefinally assembled volume filling device. FIG. 55 a is a more detailedview of the core part showing the system of channels for the guidingwire. FIGS. 55 b to 55 d are crossectional views of planes I-I, II-II,III-III and IV-IV, respectively each at the level for four channels.

The guiding wire is made of a biodegradable material that is degraded sothe segments readily become disassembled if the volume filling deviceaccidently becomes displaced from its implanted position. The segmentsdepicted are made from a biocompatible solid material and are each ofsize and shape so they readily pass through the gastrointestinal systemif the volume filling device is disassembled. When implanting the soassembled volume filling device any of the previously described methodswill be suitable.

FIG. 56 shows an embodiment of the volume filling device to beassembled. The outline of the core part and the segments is identical ashas been shown in FIG. 50 , but the flanges of the segments 563 a-d areprovided with recesses 563′a-d that match protrusions 562′a-d of theslits 562 a-d of the core part so the assembled movement device becomeslocked along two different planes. In this embodiment, these planes areperpendicularly arranged. FIG. 57 shows another embodiment of the volumefilling device according to FIG. 56 without any guiding wire and withoutany features for the guiding wire in the segments. This embodimentrequires that matching element locking elements are adapted to assistwith the disassembly if the volume filling device inadvertently becomesdisplaced from its implanted position.

It is evident from the general description and the appended claims thatmany of other ways designing the volume filling device is possiblewithout departing from this concept.

In a first alternative embodiment, the volume filling device isimplanted using a laparoscopic method instead of the intraluminal methoddescribed above. According to this embodiment, a needle or a tube-likeinstrument is inserted into the abdomen of the patient's body, and saidneedle or tube-like instrument is then used to fill the patient'sabdomen with gas. Subsequently, at least two laparoscopic trocars areinserted into the patient's body; and a camera is inserted through oneof said at least two laparoscopic trocars. Then, at least one dissectingtool through one of said at least two laparoscopic trocars, and an areaof the stomach is dissected. The volume filling device is thenintroduced into the abdominal cavity, and placed on the outside of thestomach wall. A pouch in the stomach wall for the device is created, andthe device invaginated in said pouch by providing sutures or staples tothe stomach wall, thereby positioning the volume filling device so thatthe volume of the food cavity is reduced in size by a volumesubstantially exceeding the volume of the volume filling device.

The above first alternative preferably further comprises affixing thedevice to the stomach wall by providing sutures or staples.

The above embodiment preferably further comprises providing an apparatusfor regulating the obesity treatment device from the outside of thepatient's body; and operating said apparatus to regulate the obesitytreatment device. Further, regulation of the obesity treatment deviceincludes changing the volume of a filling body of the volume fillingdevice when implanted.

The above embodiment preferably further comprises providing an injectiontype syringe comprising a fluid for injection into an implanted fillingbody; and injecting volume of fluid into said filling body.

According to an embodiment, the device is enclosed in the pouch orpartially enclosed in that the pouch is left at least partly open.Further, the pouch can be designed to exhibit only one opening.Alternatively the pouch is designed to exhibit two openings and toextend non-circumferentially around the stomach.

Preferably the pouch has a volume of more than 15 milliliters.

In a second alternative, also using a laparoscopic method instead of theintraluminal method, the initial steps are the same as described in thefirst alternative, but following dissection of the stomach, a hole iscreated in the stomach wall and a volume filling device introduced intothe abdominal cavity and through said hole into the stomach. The deviceis placed on the inside of the stomach wall, and a pouch is created onthe outside of the stomach cavity for the device placed on the inside ofthe stomach wall, and the device is invaginated in the pouch byproviding sutures or staples to the stomach wall, thereby positioningthe volume filling device so that the volume of the food cavity isreduced in size by a volume substantially exceeding the volume of thevolume filling device.

The above embodiment preferably further comprises affixing the device tothe stomach wall by providing sutures or staples. According to oneembodiment, the stomach wall is affixed to the lower part of thepatient's esophagus by providing sutures or staples.

The above second alternative preferably further comprises providing anapparatus for regulating the obesity treatment device from the outsideof the patient's body; and operating said apparatus to regulate theobesity treatment device. Further, regulation of the obesity treatmentdevice includes changing the volume of a filling body of the volumefilling device when implanted.

The above embodiment preferably further comprises providing an injectiontype syringe comprising a fluid for injection into an implanted fillingbody; and injecting volume of fluid into said filling body.

According to an embodiment, the device is enclosed in the pouch orpartially enclosed in that the pouch is left at least partly open.Further, the pouch can be designed to exhibit only one opening.Alternatively the pouch is designed to exhibit two openings and toextend non-circumferentially around the stomach.

Preferably the pouch has a volume of more than 15 milliliters.

A third alternative involves a surgical incision instead of the eitherthe intraluminal or the laparoscopic method. Here, an opening in thepatient's abdominal wall is made by surgical incision, and an area ofthe patient's stomach is dissected. The volume filling device isintroduced through said abdominal incision, and attached to the stomachwall, thereby positioning the volume filling device so that the volumeof the food cavity is reduced in size by a volume substantiallyexceeding the volume of the volume filling device.

In an alternative embodiment of the above, third alternative, theinitial steps are the same including the dissection of an area of thestomach. Following this, a pouch in the stomach wall is created for thedevice, and the device invaginated in the pouch by providing sutures orstaples to the stomach wall, thereby positioning the volume fillingdevice so that the volume of the food cavity is reduced in size by avolume substantially exceeding the volume of the volume filling device.

In yet another alternative embodiment of the above, third alternative,the initial steps are the same including the dissection of an area ofthe stomach. Following this, a hole in the stomach wall is created andthe volume filling device introduced through the hole and into thestomach. The device is then placed on the inside of the stomach wall,and a pouch on the stomach wall created for the device. The device isthen invaginated in the pouch by providing sutures or staples to thestomach wall, thereby positioning the volume filling device so that thevolume of the food cavity is reduced in size by a volume substantiallyexceeding the volume of the volume filling device.

The above embodiments of the third alternative further comprise affixingthe device to the stomach wall by providing sutures or staples.

The above embodiment preferably further comprises providing an apparatusfor regulating the obesity treatment device from the outside of thepatient's body; and operating said apparatus to regulate the obesitytreatment device. Further, regulation of the obesity treatment deviceincludes changing the volume of a filling body of the volume fillingdevice when implanted.

The above embodiment preferably further comprises providing an injectiontype syringe comprising a fluid for injection into an implanted fillingbody; and injecting volume of fluid into said filling body.

According to an embodiment, the device is enclosed in the pouch orpartially enclosed in that the pouch is left at least partly open.Further, the pouch can be designed to exhibit only one opening.Alternatively the pouch is designed to exhibit two openings and toextend non-circumferentially around the stomach.

Preferably the pouch has a volume of more than 15 milliliters.

A fourth alternative embodiment is a method comprising the steps ofinserting a needle or a tube-like instrument into the abdomen of thepatient's body; using said needle or tube-like instrument to fill thepatient's abdomen with gas; placing at least two laparoscopic trocars inthe patient's body; inserting a camera through one of said at least twolaparoscopic trocars into the patient's abdomen; inserting at least onedissecting tool through one of said at least two laparoscopic trocars;dissecting an area of the stomach; creating a pouch from the stomachwall for the device; closing the pouch by providing sutures and staples;introducing a injecting member comprising an injectable fillingmaterial; and injecting the filling material into the pouch, therebycreating a filling body that fills a volume in the patient's stomach,reducing the food cavity in size by a volume substantially exceeding thevolume of the volume filling device.

Instead of the above disclosed laparoscopic method, a surgical incisionor opening is cut in the skin to enter the patient's abdomen; an area ofthe stomach dissected; a pouch created from the stomach wall for thedevice; and said pouch closed by providing sutures and staples. Aninjecting member comprising an injectable filling material is thenintroduced; and the filling material injected into the pouch, therebycreating a filling body that reduces the food cavity in size by a volumesubstantially exceeding the volume of the volume filling device.

According to an alternative embodiment of the above, the pouch iscreated on the outside of the stomach wall, with the filling body placedagainst the inside of the stomach wall.

The method according to either of the two previous embodiments comprisescreating a hole in the stomach wall wherein the pouch is created on theinside of the stomach wall, with the filling body placed against theoutside of the stomach wall.

The method according to either of the two previous embodiments mayfurther comprise affixing the stomach wall to the lower part of thepatient's esophagus by providing sutures or staples or affixing thestomach wall to the patient's diaphragm muscle or other muscle tissue.

Preferably the pouch has a volume of more than 15 milliliters.

In a method according to either of the two previous embodiments thefilling material is preferably capable of undergoing a curing processfrom a fluid state to a semi-solid or solid state. Preferably saidcuring process is triggered by an increase in temperature from ambienttemperature to body temperature.

The invention also makes available a method of treating obesity in apatient by implanting a volume filling device that, when implanted in apatient, reduces the food cavity in size by a volume substantiallyexceeding the volume of the volume filling device, the method comprisingthe steps of:

inserting a needle or a tube-like instrument into the abdomen of thepatient's body;

using said needle or tube-like instrument to fill the patient's abdomenwith gas;

placing at least two laparoscopic trocars in the patient's body;

inserting a camera through one of said at least two laparoscopic trocarsinto the patient's abdomen;

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars;

dissecting an area of the stomach;

creating a hole in the stomach wall;

introducing a device into the abdominal cavity;

introducing the device through the hole and into the stomach;

placing the device on the outside of the stomach wall;

fixating the device placed on the outside of the stomach wall, and

thereby creating a filling body that reduces the food cavity in size bya volume substantially exceeding the volume of the volume fillingdevice.

In the above method, the device is preferably affixed to the stomachwall by providing sutures or staples.

The invention also comprises a laparoscopic instrument for providing avolume filling device to be invaginated in the stomach wall of a humanpatient to treat obesity, suitable for use with any of the laparoscopicmethods described above, the instrument comprising:

an elongated member having a proximal end and a distal end, theelongated member having a diameter less than that of a laparoscopictrocar to be introduced into the patients abdomen during a laparoscopicoperation;

a stomach pushing device for pushing the stomach wall to create atube-like shaped portion of the stomach wall protruding into the normalstomach cavity, said pushing device comprising the volume filling deviceto be invaginated by the stomach wall in the tube-like shaped portionthereof;

wherein the pushing device comprises a vacuum device to suck the stomachfundus to assist the instrument in forming the tube-like shaped portionof the stomach wall together with the pushing device, and wherein thevacuum device comprises a vacuum passageway leading from the proximal tothe distal end of the instrument and at the end portion of theinstrument, which includes the pushing device, said vacuum passageway isdivided up in multiple small openings adapted to suck the stomach wallportion to become adherent to the pushing device to further form thetube-like stomach wall portion; and

wherein the instrument comprises an insertion device adapted tointroduce the volume filling device into the tube-like shaped stomachportion.

This instrument preferably comprises at least one clamping device forholding the opening of the tube-like portion substantially closed byclamping together stomach to stomach in said opening, wherein theinstrument is adapted to place the at least one clamping device at theopening in such a way that it allows later suturing of the opening.

Further, the instrument preferably comprises an inflation device forinflating the volume filling device before or after the suturing.Further still, the instrument preferably comprises a suturing deviceadapted to suture the opening of the tube-like portion with stomach tostomach sutures for creating at least partly a closed space enclosingthe volume filling device, wherein the instrument is adapted to bewithdrawn leaving the volume filling device at least partly invaginatedin the stomach wall.

Said suturing device preferably comprises a first and second suturepositioning member provided on the elongated member situated in thestomach at the distal end thereof, and wherein the instrument furthercomprises an operation device adapted to adjust the first and secondsuturing member in a position in which the first and second suturepositioning members are in front of each other with the stomach wall onboth sides of the open end of the cup like portion, and adapted tosuture the open end of the cup like portion of the wall with a row ofstomach to stomach sutures.

Preferably said suturing device comprises an operable re-loadablemulti-suturing device, which is reloadable with sutures from outside ofthe patient's body and which is adapted to suture the open end of thecup like portion of the wall with said row of stomach to stomachsutures, wherein the row of sutures comprises two or more sutures orstaples to be sutured simultaneously.

More preferably, said suturing device comprises multiple sutures forsuturing two or more sutures simultaneously.

It is understood that a skilled person is in the position of combiningsteps, changing the order of steps, and combining elements of thedifferent embodiments of the invention without inventive effort, andwithout departing from the scope of the invention as defined in thedescription and claims.

Please note that all the embodiments or features of an embodiment aswell as any method or step of a method could be combined in any way ifsuch combination is not clearly contradictory. Please also note that thedescription in general should be seen as describing both an apparatus ordevice adapted to perform a method as well as this method in itself.

While specific embodiments of the invention have been illustrated anddescribed herein, it is realized that numerous other embodiments may beenvisaged and that numerous additional advantages, modifications andchanges will readily occur to those skilled in the art without departingfrom the spirit and scope of the invention. Therefore, the invention inits broader aspects is not limited to the specific details,representative devices and illustrated examples shown and describedherein. Accordingly, various modifications may be made without departingfrom the spirit or scope of the general inventive concept as defined bythe appended claims and their equivalents. It is therefore to beunderstood that the appended claims are intended to cover all suchmodifications and changes as fall within a true spirit and scope of theinvention. Numerous other embodiments may be envisaged without departingfrom the spirit and scope of the invention.

The invention claimed is:
 1. An apparatus for treating obesity in ahuman or animal mammal patient, the apparatus comprising: a first volumefilling device segment; and a second volume filling device segment;wherein: the first and second volume filling device segments comprise arespective interconnective structure configured to reversiblyinterconnect with one another such that the interconnective structurescan move from interconnection to disconnection, and from disconnectionto interconnection, such that the first and second volume filling devicesegments are immobilized relative each other so as to form the volumefilling device, and wherein the first and second volume filling devicesegments are adapted to be assembled into an implantable volume fillingdevice of a controlled size; the volume filling device is adapted to beat least substantially invaginated by a stomach wall portion of apatient, with an outer surface of the device resting against the stomachwall, such that the volume of the food cavity is reduced in size; andthe first and second volume filling device segments are adapted todisconnect from each other if the volume filling device is removed fromits invaginated position, to separately pass through the intestines. 2.The apparatus according to claim 1, wherein the respectiveinterconnective structure of the first and second volume filling devicesegments are complementary structures.
 3. The apparatus according toclaim 1, wherein the volume filling device has a volume of at least 125mm³ and a minimum circumference of at least 15 millimeters.
 4. Theapparatus according to claim 1, wherein at least a portion of an outersurface of the first and second volume filling device segments comprisesa biocompatible material.
 5. The apparatus according to claim 1, whereinthe first and second volume filling device segments are adapted to passthrough a trocar, for assembly and implantation of said volume fillingdevice into the abdominal cavity.
 6. The apparatus according to claim 1,wherein the first and second volume filling device segments have aflexible outer shape adapted to pass through a trocar.
 7. The apparatusaccording to claim 1, wherein the first and second volume filling devicesegments are adapted to have a shape allowing them to be assembled intosaid volume filling device, when implanted.
 8. The apparatus accordingto claim 1, wherein the first and second volume filling device segmentsare hollow with a flexible outer surface.
 9. The apparatus according toclaim 1, wherein the first and second volume filling device segments areadapted to be filled with at least one of a fluid a foam, a gel or afluid that hardens to a solid material.
 10. The apparatus according toclaim 1, wherein the first and second volume filling device segments areformed of a massive material.
 11. The apparatus according to claim 1,wherein the first and second volume filling device segments are adaptedto temporary be holding their assembled position.
 12. The apparatusaccording to claim 1, wherein the first and second volume filling devicesegments are adapted to permanently hold their assembled position by theinvaginated stomach wall.
 13. The apparatus according to claim 1,wherein the first and second volume filling device segments are adaptedto temporary be holding their assembled position by an adhesive.
 14. Theapparatus according to claim 1, wherein the first and second volumefilling device segments are of a size that admits free passage through agastrointestinal system.